Pay or shift range: $143,000 CAD to $197,000 CADThe estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.DescriptionThe Big PictureThe Senior Manager, Quality Engineer is responsible for coaching and directing the quality team in establishing, maintaining and improving the company's quality system according to regulatory and company requirements. Supports and executes delegated Quality System Management Representative responsibilities, as assigned by the Director.Your Impact Through InnovationEstablishes and maintains adequate quality systems, policy, objectives, and metrics and ensures resources are adequate, appropriate and competent to support the quality system to ensure quality and reliability of products and services supplied by Baylis Medical TechnologiesActs as a delegate of the Quality System Management Representative, as assigned by the DirectorEnsures compliance of the quality system to ISO 13485 and government regulations in marketed jurisdictionsPartners with the Director to develop and deploy quality strategies aligned with business objectives, driving continuous improvement in product and service qualityChampions the quality culture and builds outstanding partnerships with operations, supply chain, manufacturing, regulatory, research and development, sales, and other functionsDevelops quality capabilities, training and coaching for the quality team and rest of company as applicable; Build future leaders for the organizationMakes critical, creative and strategic decisions as a result of analysis of available information including risk-assessment for the patient and for the businessProvides senior oversight for design and manufacturing quality activities, ensuring appropriate application of design controls, risk management, and production controls across the product lifecycle.Partners with R&D, Manufacturing, and Operations to ensure effective transfer of new products and technologies, including readiness of quality processes, controls, and risk documentation.Ensures product and process risk management activities are appropriately defined, implemented, and maintained in alignment with ISO 14971.Provides governance and direction for nonconforming material and MRB processes, ensuring consistent decision making, escalation,



and systemic corrective action.Oversees the supplier quality framework, including expectations for supplier qualification, performance monitoring, change management, and issue escalation, while delegating execution to functional quality teams.Ensures manufacturing quality controls and inspection strategies are fit for purpose, risk based, and aligned with regulatory and business requirements.Provides senior oversight of sterility assurance and environmental control programs, ensuring appropriate governance, risk management, escalation, and continuous improvement. Ensures responsibilities, controls, and monitoring are clearly defined and effectively executed by functional teams.Possible need to travel.Other duties as required.Required Skills:Minimum Bachelor’s degree in a scientific or engineering disciplineMinimum of 8 years’ experience in medical device industry or equivalent industryMinimum of 5 years’ experience in manufacturing environmentMinimum of 5 years’ experience leading and coaching others in a Quality roleDemonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower othersDemonstrated working knowledge of and experience with U.S. FDA medical device regulatory requirements, including the Quality Management System Regulation (QMSR) and ISO 13485, as well as Canadian Medical Devices Regulations (CMDR)Strong understanding of ISO 14971 risk management principlesDemonstrated experience in hosting and facilitating audits and regulatory agency inspections with successful outcomes.Demonstrated skills in achieving results and managing others to achieve objectivesDemonstrated experience in making decisions to resolve the most complex problems and providing sound compliance advice and directionDemonstrated successful interdisciplinary collaboration in a team settingStrong expertise in analytical methods, quality systems and continuous improvement methodsSkilled interpersonally; strong communication,



negotiation and conflict management skillsDemonstrated proficiency in project management, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientationAsset Skills:Advanced degree in engineering, life sciences or related fieldOur Distinctive EdgeEffortless commute: say goodbye to commuting challenges/hassles with our complimentary shuttles and subsidized transit options, making your journey to work a breeze.Work-life integration: Embrace a well-balanced work-life rhythm through our hybrid model and flexible hours, empowering you to thrive both personally and professionally.Making a difference: Be a force for good with one dedicated day off for impactful volunteering, supporting causes close to your heart.Nurturing your career: Propel your career forward with abundant opportunities for on-site training, workshops, and personal development.Rewards that count: Reap the advantages of our comprehensive rewards package, including tuition reimbursement and a health spending account.Unleash your spirit: Join a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities – fostering camaraderie and fun.Our ImpactBaylis Medical Technologies is a leader in the development and manufacturing of innovative medical devices in the fields of radiology and cardiovascular. Headquartered in Canada, the company also provides contract manufacturing services to some of the world’s leading medical device companies.Baylis Medical Technologies is an equal opportunity employer and encourages applications from all qualified individuals.Please inform us if you require any accommodation during the recruitment process.Take the LeapWe are looking for talented individuals, like yourself, to join Baylis Medical Technologies and make a meaningful impact in the lives of patients. Be part of our mission to revolutionize patient care through cutting‑edge technology and breakthrough solutions.Are you ready to join us? Apply today and let’s shape the future of healthcare together!Want an inside look at careers and life at Baylis? See all our current job opportunities here and follow us on LinkedIn !While we thank all applicants, only those being considered for an interview will be contacted.#J-18808-Ljbffr

📌 Senior Manager, Quality Engineering - C$143,000 - C$197,000 A Year (Toronto)
🏢 Baylis Medical Technologies
📍 Toronto